Postmenopausal OsteoporosisPhase 2popNCT01834105
Molecular Mechanism of POP Kidney Yin Deficiency Syndrome From the Interventional Effects of CLCF1
A Phase 2 study testing Liuwei Dihuang Pills in people with Postmenopausal Osteoporosis, run by Fujian Academy of Traditional Chinese Medicine at 1 site in China.
Trial summary
This study use RT-PCR and Western Blot technique to detect the expression of CLCF1 mRNA and protein in POP Kidney Yin deficiency group and healthy group to verify the relevance between CLCF1 and POP the kidney Yin deficiency syndrome.Through siRNA and overexpression,observe the mRNA and protein 's expression of… Read more about this study
- Who is it for?
- Ages 45 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postmenopausal Osteoporosis
- What is being tested?
- Liuwei Dihuang Pills
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- Jan 2012to Dec 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The Participants who volunteer to be test subjects, and can accept experimental drugs, and promise to finish the course should sign the informed consent.
- Female ages 45 to 75 had gone through natural menopause before two years
- In accordance with the western medicine diagnostic criteria of osteoporosis and belong to kidney Yin deficiency syndrome differentiation of traditional Chinese medicine certificate;
- In accordance with the western medicine diagnostic criteria;
- In accordance with TCM diagnostic methods; .If any of the above answers are no, The subjects couldn't in the study.
Who cannot join
- Do not accord with standard of the western medicine diagnosis and TCM diagnostic methods
- Age: <44 and > 76 years old;
- With hyperparathyroidism, osteomalacia, rheumatoid arthritis, multiple myeloma and other serious complications such as secondary osteoporosis; Late or deformity, disability, loss of labor;
- With cardiovascular, cerebrovascular, liver, kidney and hematopoietic system and other serious primary diseases;
- Psychosis or alzheimer's patients;
- Nearly three months, the use of hormone replacement therapy (HRT) and taking calcitonin, nearly six months has used double phosphonic acid salt for 15 days, etc.;
- This medicine allergic constitution or composition of known to have allergies;
- In a critical condition, It's difficult to make exact evaluators to efficacy and safety of the new drugs;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fujian Institute of Trational Chiness Medicine
Fuzhou, Fujian, 3530003
xie bin ying, Bachelor, 86-0591-83570943, yjykyb@163.com
About this study
Official title: Study on the Molecular Mechanism of Postmenopausal Osteoporosis With Kidney Yin Deficiency Syndrome From CLCF1 Interventing on JAK-STAT Signaling Pathways
This study use RT-PCR and Western Blot technique to detect the expression of CLCF1 mRNA and protein in POP Kidney Yin deficiency group and healthy group to verify the relevance between CLCF1 and POP the kidney Yin deficiency syndrome.Through siRNA and overexpression,observe the mRNA and protein 's expression of CBP、JAK1、STAT4 and the protein phosphorylation of JAK1、STAT4 in JAK-STAT signal to reveal the CLCF1 regulate the CBP's mechanism.Use the Liuwei Dihuang Pills to detect the effect of treatment ,compare use or not the Liuwei Dihuang Pills to detect the mRNA and protein 's expression of CLCF1、CBP etc.Aim to clarify the POP kidney Yin deficiency molecular mechanism.
- Conditions
- Postmenopausal Osteoporosis
- Being tested
- Liuwei Dihuang Pills
- Keywords
- Postmenopausal osteoporosis; Kidney Yin deficiency syndrome; Liuwei dihuang pill; CLCF1; JAK - STAT signal pathway
- Medical subject headings
- Osteoporosis, Postmenopausal, Crisponi syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liuwei Dihuang PillsDrug
| Study group | Role | What they receive |
|---|---|---|
| Liuwei Dihuang Pills | Experimental | Not described Receives: Drug: Liuwei Dihuang Pills |
What is being measured
The primary outcome is the main question the study is designed to answer.
osteoporosis treatment within six months of study enrollment
Measured: Liuwei Dihuang Pills therapy (up to six months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2013 (estimated)
- Study startJan 2012
- Primary completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postmenopausal OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Academy of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01834105
- Sponsor's protocol ID
- 81173280
- Acronym
- pop
- Status last verified
- Apr 2013
- First submitted
- 14 Apr 2013
- Last updated
- 18 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Molecular Mechanism of Postmenopausal Osteoporosis With Kidney Yin Deficiency Syndrome From CLCF1 Interventing on JAK-STAT Signaling Pathways
- ClinicalTrials.gov ID
- NCT01834105
- Acronym / sponsor ID
- pop / 81173280
- Conditions
- Postmenopausal Osteoporosis
- Keywords
- Postmenopausal osteoporosis; Kidney Yin deficiency syndrome; Liuwei dihuang pill; CLCF1; JAK - STAT signal pathway
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Fujian Academy of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Dec 2014 (estimated)
- First posted
- 17 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study use RT-PCR and Western Blot technique to detect the expression of CLCF1 mRNA and protein in POP Kidney Yin deficiency group and healthy group to verify the relevance between CLCF1 and POP the kidney Yin deficiency syndrome.Through siRNA and overexpression,observe the mRNA and protein 's expression of CBP、JAK1、STAT4 and the protein phosphorylation of JAK1、STAT4 in JAK-STAT signal to reveal the CLCF1 regulate the CBP's mechanism.Use the Liuwei Dihuang Pills to detect the effect of treatment ,compare use or not the Liuwei Dihuang Pills to detect the mRNA and protein 's expression of CLCF1、CBP etc.Aim to clarify the POP kidney Yin deficiency molecular mechanism.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Liuwei Dihuang Pills | Experimental | Drug: Liuwei Dihuang Pills |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The Participants who volunteer to be test subjects, and can accept experimental drugs, and promise to finish the course should sign the informed consent.
- Female ages 45 to 75 had gone through natural menopause before two years
- In accordance with the western medicine diagnostic criteria of osteoporosis and belong to kidney Yin deficiency syndrome differentiation of traditional Chinese medicine certificate;
- In accordance with the western medicine diagnostic criteria;
- In accordance with TCM diagnostic methods; .If any of the above answers are no, The subjects couldn't in the study.
Key exclusion criteria (8 listed)
- Do not accord with standard of the western medicine diagnosis and TCM diagnostic methods
- Age: <44 and > 76 years old;
- With hyperparathyroidism, osteomalacia, rheumatoid arthritis, multiple myeloma and other serious complications such as secondary osteoporosis; Late or deformity, disability, loss of labor;
- With cardiovascular, cerebrovascular, liver, kidney and hematopoietic system and other serious primary diseases;
- Psychosis or alzheimer's patients;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liuwei Dihuang Pills | Drug | Liuwei Dihuang Pills |
Primary outcome
osteoporosis treatment within six months of study enrollment
Time frame: Liuwei Dihuang Pills therapy (up to six months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Liuwei Dihuang Pills in people with Postmenopausal Osteoporosis, run by Fujian Academy of Traditional Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
osteoporosis treatment within six months of study enrollment (time frame: Liuwei Dihuang Pills therapy (up to six months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2013; AzTrials last refreshed its copy on 8 Nov 2026.